The Sunrise SpO2 and Pulse Rate Accuracy Validation Study (S2-SOPRAV)
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|ClinicalTrials.gov Identifier: NCT05386836|
Recruitment Status : Completed
First Posted : May 23, 2022
Last Update Posted : June 28, 2022
The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter. Testing is conducted under normal office environment conditions. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70-100% SaO2.
A secondary goal is to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered.
|Condition or disease||Intervention/treatment||Phase|
|Validation Study||Device: Pulse oximeter validation population||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-center Study Assessing the SpO2 and Pulse Rate Accuracy of the Sunrise Sensor 2 Compared to Arterial Blood Samples Oxygen Saturation Assessed by CO-oximetry and ECG Respectively, Under Non-motion Conditions in Healthy Adults|
|Actual Study Start Date :||May 24, 2022|
|Actual Primary Completion Date :||June 21, 2022|
|Actual Study Completion Date :||June 21, 2022|
Experimental: Healthy adult volunteers
All subjects within this single arm of the study will undergo the validation experiment as described in the description
Device: Pulse oximeter validation population
Evaluation of the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter.
- SpO2 ARMS determination [ Time Frame: Within 1 month after subject recruitment ]SpO2 accuracy root-mean-square (ARMS) determination for the range of 70- 100%., i.e., the RMS difference between measured values and reference values.
- Pulse rate ARMS determination [ Time Frame: Within 1 month after subject recruitment ]Pulse rate accuracy root-mean-square (ARMS) determination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05386836